1. Golgi Protein-73 Shows Promise as a Sensitive Serum Marker for HCC Slideset on: Marrero J, Romano P, Nikolaeva O, et al. GP73, a resident golgi glycoprotein, is a novel serum marker for hepatocellular carcinoma. J Hepatol. 2005;43:1007-1012.

2. clinicaloptions.com/hep Golgi Protein 73 as Serum Marker for HCC Background  Incidence of hepatocellular carcinoma (HCC) rising in US  Current diagnostic tools inadequate –Alpha-fetoprotein (AFP) in serum; low positive predictive value –Liver ultrasound; accuracy dependent on skills of technician  Golgi protein (GP73) upregulated in patients with liver disease and in animal models of HCC  Current study evaluated sensitivity and specificity of serum GP73 levels for diagnosing HCC Marrero J, et al. J Hepatol. 2005;43:1007-1012.

3. clinicaloptions.com/hep Golgi Protein 73 as Serum Marker for HCC Study Design  Cases and controls recruited from University of Michigan, 2001-2004  GP73 levels in sera from patients measured with Western blot –Triplicate determinations were performed for each serum sample –Interassay variability: 8% –Intra-assay variability: 10%  HCC case patients –HCC diagnosed by histopathology (preferred) or 2 imaging method  Control group 1 –No history of liver disease –< 40 g alcohol/week –No risk factors for hepatitis  Control group 2 –Cirrhosis patients –Matched to HCC patients by age, sex, race Marrero J, et al. J Hepatol. 2005;43:1007-1012.

4. clinicaloptions.com/hep Golgi Protein 73 as Serum Marker for HCC Study Results Serum Marker, Median Relative Units (Range) No Liver DiseaseCirrhosisEarly HCC*All HCCP Value † GP73 1.4 (0.6-13.9) 4.6 (0.6-27.6) 12.8 (1-50) 13.2 (1-53) <.0001 AFP 2.5 (1.2-7.8) 5.9 (0.3-613) 10.9 (1.4-134,000) 15.6 (0.9-347,000) <.0001  GP73 detected in serum of all patients –Levels significantly higher in patients with cirrhosis or HCC than in controls –Levels differentiated between early HCC and cirrhosis Marrero J, et al. J Hepatol. 2005;43:1007-1012. *United Network for Organ Sharing modified TNM stages I and II. † P =.001 for early HCC vs cirrhosis in AFP measure.

5. clinicaloptions.com/hep Golgi Protein 73 as Serum Marker for HCC GP73 Appears to Be a Sensitive and Specific Marker for HCC Marrero J, et al. J Hepatol. 2005;43:1007-1012. Serum Marker, Median Relative Units (Range) AUROC* (95% CI)Sensitivity, %Specificity, % GP73 0.79 (0.72-0.82)6986 AFP 0.61 (0.59-0.71)3096 GP73 in early HCC 0.77 (0.704-0.826)6288 AFP in early HCC 0.62 (0.55-0.69)2597 AUROC, area under the receiver operating curve; CI, confidence interval. *P =.001 for GP73 vs AFP; P <.0001 for GP73 vs AFP.

6. clinicaloptions.com/hep Golgi Protein 73 as Serum Marker for HCC Key Conclusions  GP73 validated as serum indicator of HCC –Levels significantly higher in HCC patients than those with cirrhosis or healthy livers  GP73 serum levels may be superior to AFP levels for detecting HCC –Elevated in patients with normal AFP; more sensitive  GP73 serum levels elevated even in early HCC –Further validation needed to confirm the role of GP73 in the early detection of HCC Marrero J, et al. J Hepatol. 2005;43:1007-1012.